<?xml version="1.0" encoding="utf-8"?>
<!DOCTYPE trials [
<!ELEMENT trials (trial+)>

<!ELEMENT trial (main,contacts,countries,criteria,health_condition_code,health_condition_keyword,intervention_code,
          intervention_keyword,primary_outcome,secondary_outcome,secondary_sponsor,secondary_ids,source_support,ethics_reviews)>

<!ELEMENT main (trial_id,utrn?,reg_name,date_registration,primary_sponsor,public_title,acronym?,scientific_title,scientific_acronym?,
          date_enrolment,type_enrolment,target_size,recruitment_status,url?,study_type,study_design,phase,hc_freetext?,i_freetext?,results_actual_enrolment,results_date_completed,results_url_link,results_summary,           results_date_posted,results_date_first_publication,results_baseline_char,results_participant_flow,results_adverse_events,results_outcome_measures,results_url_protocol,results_IPD_plan, results_IPD_description)>
<!ELEMENT trial_id (#PCDATA)>
<!ELEMENT utrn (#PCDATA)>
<!ELEMENT reg_name (#PCDATA)>
<!ELEMENT date_registration (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT primary_sponsor (#PCDATA)>
<!ELEMENT public_title (#PCDATA)>
<!ELEMENT acronym (#PCDATA)>
<!ELEMENT scientific_title (#PCDATA)>
<!ELEMENT scientific_acronym (#PCDATA)>
<!ELEMENT date_enrolment (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT type_enrolment (#PCDATA)>
<!ELEMENT target_size (#PCDATA)>
<!ELEMENT recruitment_status (#PCDATA)><!-- Pending,Recruiting,Suspended,Complete,Other -->
<!ELEMENT url (#PCDATA)>
<!ELEMENT study_type (#PCDATA)><!-- interventional,observational -->
<!ELEMENT study_design (#PCDATA)>
<!ELEMENT phase (#PCDATA)>
<!ELEMENT hc_freetext (#PCDATA)>
<!ELEMENT i_freetext (#PCDATA)>
<!ELEMENT results_actual_enrolment (#PCDATA)>
<!ELEMENT results_date_completed (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_url_link (#PCDATA)>
<!ELEMENT results_summary (#PCDATA)>
<!ELEMENT results_date_posted (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_date_first_publication (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT results_baseline_char (#PCDATA)>
<!ELEMENT results_participant_flow (#PCDATA)>
<!ELEMENT results_adverse_events (#PCDATA)>
<!ELEMENT results_outcome_measures (#PCDATA)>
<!ELEMENT results_url_protocol (#PCDATA)>
<!ELEMENT results_IPD_plan (#PCDATA)>
<!ELEMENT results_IPD_description (#PCDATA)>


<!ELEMENT contacts (contact+)>
<!ELEMENT contact (type,firstname,middlename,lastname,address,city,country1,zip,telephone,email,affiliation)>
<!ELEMENT type (#PCDATA)><!-- Public,Scientific -->
<!ELEMENT firstname (#PCDATA)>
<!ELEMENT middlename (#PCDATA)>
<!ELEMENT lastname (#PCDATA)>
<!ELEMENT address (#PCDATA)>
<!ELEMENT city (#PCDATA)>
<!ELEMENT country1 (#PCDATA)>
<!ELEMENT zip (#PCDATA)>
<!ELEMENT telephone (#PCDATA)>
<!ELEMENT email (#PCDATA)>
<!ELEMENT affiliation (#PCDATA)>

<!ELEMENT countries (country2+)>
<!ELEMENT country2 (#PCDATA)>

<!ELEMENT criteria (inclusion_criteria,agemin,agemax,gender,exclusion_criteria)>
<!ELEMENT inclusion_criteria (#PCDATA)>
<!ELEMENT agemin (#PCDATA)>
<!ELEMENT agemax (#PCDATA)>
<!ELEMENT gender (#PCDATA)>
<!ELEMENT exclusion_criteria (#PCDATA)>

<!ELEMENT health_condition_code (hc_code+)>
<!ELEMENT hc_code (#PCDATA)>

<!ELEMENT health_condition_keyword (hc_keyword+)>
<!ELEMENT hc_keyword (#PCDATA)>

<!ELEMENT intervention_code (i_code+)>
<!ELEMENT i_code (#PCDATA)>

<!ELEMENT intervention_keyword (i_keyword+)>
<!ELEMENT i_keyword (#PCDATA)>

<!ELEMENT primary_outcome (prim_outcome+)>
<!ELEMENT prim_outcome (#PCDATA)>

<!ELEMENT secondary_outcome (sec_outcome+)>
<!ELEMENT sec_outcome (#PCDATA)>

<!ELEMENT secondary_sponsor (sponsor_name+)>
<!ELEMENT sponsor_name (#PCDATA)>

<!ELEMENT secondary_ids (secondary_id+)>
<!ELEMENT secondary_id (sec_id,issuing_authority)>
<!ELEMENT sec_id (#PCDATA)>
<!ELEMENT issuing_authority (#PCDATA)>

<!ELEMENT source_support (source_name+)>
<!ELEMENT source_name (#PCDATA)>

<!ELEMENT ethics_reviews (ethics_review+)>
<!ELEMENT ethics_review (status,approval_date,contact_name,contact_address,contact_phone,contact_email)>
<!ELEMENT status (#PCDATA)><!-- Not approved,Approved,NA -->
<!ELEMENT approval_date (#PCDATA)><!-- dd/mm/yyyy -->
<!ELEMENT contact_name (#PCDATA)>
<!ELEMENT contact_address (#PCDATA)>
<!ELEMENT contact_phone (#PCDATA)>
<!ELEMENT contact_email (#PCDATA)>
]>
<trials>
  <trial>
    <main>
      <trial_id>IRCT20210621051642N1</trial_id>
      <utrn></utrn>
      <reg_name>IRCT</reg_name>
      <date_registration>2021-07-05</date_registration>
      <primary_sponsor>Sabzevar University of Medical Sciences</primary_sponsor>
      <public_title>Evaluation of therapeutic effect of Simospan syrup on covid-19</public_title>
      <acronym></acronym>
      <scientific_title>Evaluation of therapeutic effect of Simospan syrup (contains of Thymus vulgaris, Hedera helix, Honey and Vitamin C) on duration of hospitalization in covid-19 patients</scientific_title>
      <scientific_acronym></scientific_acronym>
      <date_enrolment>2021-06-26</date_enrolment>
      <type_enrolment>anticipated</type_enrolment>
      <target_size>52</target_size>
      <recruitment_status>Complete</recruitment_status>
      <url>https://irct.ir/trial/56998</url>
      <study_type>interventional</study_type>
      <study_design>Randomization: Randomized, Blinding: Single blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization will be done based on the table of random numbers using Excel software and with the Randbetween command between 52 samples. The control group(A) does not receive any treatment over common treatment.The 26 numbers of intervention group(B) receives the simospan syrup,. Patients numbers from 000-026 and 027-052 are considered for groups A and B respectively, Blinding description: Analyzer and data collecting man not be aware of intervention type and participants in control and intervention groups.so the trial will be run as single-blind.</study_design>
      <phase>2-3</phase>
      <hc_freetext>covid-19.</hc_freetext>
      <i_freetext>Intervention 1: Control group: routine treatment based on physician's order. Intervention 2: Intervention group:  routine treatment based on physician's order and simospan syrup (every 8 hours 6 cc for 5 days).</i_freetext>
      <results_actual_enrolment></results_actual_enrolment>
      <results_date_completed></results_date_completed>
      <results_url_link></results_url_link>
      <results_summary></results_summary>
      <results_date_posted></results_date_posted>
      <results_date_first_publication></results_date_first_publication>
      <results_baseline_char></results_baseline_char>
      <results_participant_flow></results_participant_flow>
      <results_adverse_events></results_adverse_events>
      <results_outcome_measures></results_outcome_measures>
      <results_url_protocol></results_url_protocol>
      <results_IPD_plan>Undecided - It is not yet known if there will be a plan to make this available</results_IPD_plan>
      <results_IPD_description>Justification or reason for indecision in sharing IPD is I have not yet decided.its release program is not clear.</results_IPD_description>
    </main>
    <contacts>
      <contact>
        <type>public</type>
        <firstname>Sajad Seyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Heshmatieh hospital, Asadabadi street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873140</zip>
        <telephone>+98 51 4401 1954</telephone>
        <email>sajadseyedi2004@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
      <contact>
        <type>scientific</type>
        <firstname>Sajad Seyedi</firstname>
        <middlename></middlename>
        <lastname></lastname>
        <address>Heshmatie hospital, Asadabadi street</address>
        <city>Sabzevar</city>
        <country1>Iran (Islamic Republic of)</country1>
        <zip>9613873140</zip>
        <telephone>+98 51 4401 1954</telephone>
        <email>sajadseyedi2004@gmail.com</email>
        <affiliation>Sabzevar University of Medical Sciences</affiliation>
      </contact>
    </contacts>
    <countries>
      <country2>Iran (Islamic Republic of)</country2>
    </countries>
    <criteria>
      <inclusion_criteria>Age limitation (30-60 years old)
Hospitalized patients with CT-scan findings  in favor of Covid-19 disease
Hospitalized patients with the amount of blood oxygen saturation below 93%
Hospitalized patients with Chest X-ray findings in favor of pneumonia
Hospitalized patients without underlying disease</inclusion_criteria>
      <agemin>30 years</agemin>
      <agemax>60 years</agemax>
      <gender>Both</gender>
      <exclusion_criteria>Pregnancy and lactation
End-stage Covid-19 patients
Patients diagnosed with underlying disease and organ damage</exclusion_criteria>
    </criteria>
    <health_condition_code>
      <hc_code>U07.1</hc_code>
    </health_condition_code>
    <health_condition_keyword>
      <hc_keyword>COVID-19, virus identified</hc_keyword>
    </health_condition_keyword>
    <intervention_code>
      <i_code>Treatment - Other</i_code>
      <i_code>Treatment - Drugs</i_code>
    </intervention_code>
    <intervention_keyword>
      <i_keyword>Control group: routine treatment based on physician's order</i_keyword>
      <i_keyword>Intervention group:  routine treatment based on physician's order and simospan syrup (every 8 hours 6 cc for 5 days)</i_keyword>
    </intervention_keyword>
    <primary_outcome>
      <prim_outcome>The spent time to illness improvement. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Variable type is qualitative and its scale is nominal.the criterion of recovery records and descripts based on observations of data collecting man in checklist.relative criterion based on clinical symptoms:1-non-admission along with the return of normal activity-2-non-admission along without the return of normal activity-3-admission without the need for oxygentherapy-4-admission with the need for oxygentherapy-5-admission with the need to receive high speed oxygen from the nose or non invasive ventilation or both-6-admission with the need to receive oxygen therapy with invasive ventilation or oxygen therapy from non pulmonary pathways or both-7- patient's death.</prim_outcome>
      <prim_outcome>Discharge from hospital. Timepoint: After the start of intervention. Method of measurement: Duration of hospitalization.</prim_outcome>
    </primary_outcome>
    <secondary_outcome>
      <sec_outcome>The blood level of ALT enzyme. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Spectrometer.</sec_outcome>
      <sec_outcome>The blood level of BUN. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Spectrometer.</sec_outcome>
      <sec_outcome>The blood level of creatinine. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Spectrometer.</sec_outcome>
      <sec_outcome>The blood level of AST enzyme. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Spectrometer.</sec_outcome>
      <sec_outcome>RBC count. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Cell counter.</sec_outcome>
      <sec_outcome>WBC count. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Cell counter.</sec_outcome>
      <sec_outcome>The blood level of HG. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Auto analyzer machine.</sec_outcome>
      <sec_outcome>The blood level of HCT. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Auto analyzer machine.</sec_outcome>
      <sec_outcome>CRP blood test. Timepoint: Before and 5 days after the start of intervention. Method of measurement: ELISA kits.</sec_outcome>
      <sec_outcome>ESR test. Timepoint: Before and 5 days after the start of intervention. Method of measurement: Wintrobe method.</sec_outcome>
    </secondary_outcome>
    <secondary_sponsor>
      <sponsor_name></sponsor_name>
    </secondary_sponsor>
    <secondary_ids>
      <secondary_id>
        <sec_id></sec_id>
        <issuing_authority></issuing_authority>
      </secondary_id>
    </secondary_ids>
    <source_support>
      <source_name>Sabzevar University of Medical Sciences</source_name>
    </source_support>
    <ethics_reviews>
      <ethics_review>
        <status>Approved</status>
        <approval_date>2021-06-20</approval_date>
        <contact_name>Ethics committee of Sabzevar University of Medical Sciences</contact_name>
        <contact_address>Nuclear martyrs boulevard-Above the memorial of the anonymous martyrs-sabzevar university of med-sci pardis Sabzevar Razavi Khorasan Iran (Islamic Republic of)</contact_address>
        <contact_phone></contact_phone>
        <contact_email></contact_email>
      </ethics_review>
    </ethics_reviews>
  </trial>
</trials>
